Job Purpose: Cell culture subject matter expert, responsible for technology transfer, scale-up, lab scale process mod-eling, process validation, and select regulatory section preparation to support the commercial launch and manufacture of new vaccines.
• Subject matter expert in cell culture process design and scale up for the site and the global technology development organization.
• Responsible for managing a team of 4-5 scientists, dealing with performance evaluations and is-sues and developing personnel.
• Lead cross-site & cross-functional team to establish process transfer, scale-up & validation plan, product comparability protocol and risk mitigation options.
• Establishes milestones and deliverables for process transfer and validation runs in collaboration with other departments at the site and other site(s); Ensure successful process transfer within schedule and cost through proactive identification of risks and mitigation steps; Drive implementation of risk mitigation steps at Novartis sites and at contract labs.
• Provide manufacturing support for existing manufacturing processes at the US and European manufacturing sites using Six-sigma methodologies including troubleshooting and yield and robustness improvements.
• Plans and potentially supervises multiple projects internally, at other sites and at external manufacturers requiring initiative and judgment.
• Plans, assigns, directs and evaluates the work of technical staff when assigned to the project. May supervise lower level scientists. Performs other duties as assigned.
• Prepare project update presentations for senior management reviews; prepare sections of select milestones reports for the site.
• Proactively identify potential issues and manage cross-functional resolution.
• Develop creative solutions to technical and organizational problems in order to keep projects on schedule.
• Ph.D. with at least 5 years’ related experience or BS/MS with 14 years' related experience Degree should be in a science or engineering discipline.
• Relevant pharmaceutical development and/or manufacturing experience.
• Ability to lead team and manage effectively.
• Must have work experience in process transfer, GMP manufacturing, process development and product launch in the biotechnology and/or vaccine industry.
• Process experience with viral gene vectors or vaccines is preferred.
• Must be able to effectively partner with diverse team members from various functions, multiple countries and members at various levels in organization.
• Must be a self-starter, be able to work with minimal supervision in a matrix environment and effectively manage multiple projects.
• Travel of 10% may be required (including international) to support project activities.